Kornimate/medical-research-clean huggingface dataset:
effect of aerobic exercise on blood pressure changes

Conditions: Hypertension; Cardiovascular Diseases

Summary: this study will evaluate the effect of an aerobic training program versus a strength training program on the autonomic nervous system at rest and in response to challenge.

the purpose of this study is to compare the effectiveness of an aerobic exercise program versus a strength training program in altering rr interval and blood pressure variability as indices of autonomic nervous system regulation of the cardiovascular system. subjects will be tested at rest and in response to challenge. this study will enroll healthy, young (age 18-45) sedentary individuals at columbia university medical center and st. john's university. at an initial screening visit, potential participants will be screened for exercise activity and will also undergo a test of aerobic capacity. subjects will be eligible if they are not exercising regularly and do not exceed american heart association standards for average fitness (vo2max ≤ 43 and 37 ml/kg/min for men and women respectively). exclusion criteria include current symptoms of affective disorder, psychosis, or substance abuse, current usage of psychotropic medication, and any medical condition that affected the autonomic nervous system or cardiovascular system. eligible participants will then be randomly assigned to 12 weeks of either an aerobic conditioning program or a strength training program. at study entry, heart rate, respiratory rate, and blood pressure will be measured; an ecg will be used to measure heart activity. questionnaires will be completed to assess anger, tension, depression, and fatigue. participants in the aerobic conditioning program will attend four 1-hour exercise sessions per week, which will focus on increasing cardiovascular fitness through running and other forms of aerobic exercise. the strength training program will also include four sessions per week, with the focus on increasing muscle endurance and strength. at the end of the 12-week programs, participants will begin a 4-week period of deconditioning, during which they will discontinue all exercise. evaluations will be repeated at the end of the 12-week programs, and at the end of the 4-week deconditioning period.

Eligibility criteria:
inclusion criteria: * average cardiorespiratory fitness level, as defined by the american heart association (vo2 max \[maximum oxygen consumption\] less than 43 ml/kg/min for men and less than 37 ml/kg/min for women) * english speaking * ambulatory * sedentary exclusion criteria: * use of psychotropic medications * past or current psychiatric disorder * heart disease * high blood pressure * diabetes mellitus * neurologic disease

Keywords: blood pressure, high
immunomodulatory therapy in women with autoimmune premature ovarian insufficiency

Conditions: Autoimmune Diseases; Premature Ovarian Insufficiency

Summary: title: effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency (poi) trial objectives and purpose: to study if rituximab therapy can improve ovarian response to gonadotropin stimulation and menstrual function in women with autoimmune poi. treatment: controlled ovarian hyperstimulation before and four months after an infusion of 1-gram rituximab (mabthera®) twice with two weeks interval. follow-up period 12 months after infusion. primary outcome: number of antral follicles and the size of the largest follicle in response to ovarian stimulation. secondary outcomes: 1. reestablishment of spontaneous menstrual bleedings during the 12 months' study period 2. ovulation during the 12 months' study period 3. change in b-cell count, autoantibody indices and immunoglobulin levels (igg) after treatment safety outcomes: all adverse events. of particular relevance are any hospital admissions, infections and allergic reactions. study population: fifteen women with autoimmune poi defined as absence of menstruation \> 6 months and elevated serum level of follicle stimulation hormone \> 40 international units (iu)/l. inclusion criteria: autoimmune poi defined as presence of autoantibodies against 21-hydroxylase (oh), side chain cleavage enzyme (scc), 17-oh and/or neuronal apoptosis inhibitory protein (nacht) leucine-rich-repeat protein 5 (nalp5) or other relevant autoantibodies; 18-35 yrs of age; body mass index 19-30. exclusion criteria: hypersensitivity to rituximab; severe infection; severe immunosuppression; cardiac disease; cancer; benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst; vaginal bleeding of unknown aetiology. time plan: the study is expected to start the spring 2017. it is expected to be closed spring 2023.


Eligibility criteria:
inclusion criteria: 1. autoimmune premature ovarian insufficiency defined as presence of autoantibodies against 21-oh, scc, 17-oh and/or nalp5 or other relevant autoantibodies 2. 18-35 yrs of age 3. body mass index 19-30. 4. in fertile females, willingness to comply with effective contraceptive methods. 5. ability to provide informed consent exclusion criteria: 1. documented hypersensitivity or intolerance to rituximab 2. active, severe infection 3. severe immunosuppression 4. severe cardiac disease 5. cancer 6. benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst 7. vaginal bleeding of unknown aetiology 8. hormone replacement therapy (hrt) within four weeks prior study entry. 9. pregnant or lactating women 10. concurrent treatment with other immunosuppressive drugs 11. vaccination within 4 weeks of infusion of study medication 12. severe psychiatric disorder 13. patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with rituximab.
a study to evaluate the effect of 2 drugs on the pharmacokinetics of bms-986205 in healthy subjects

Conditions: Malignancies Multiple

Summary: assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of bms-986205.

a randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of bms-986205. safety and tolerability data to be collected and assessed as well.

Eligibility criteria:
inclusion criteria: * body mass index 18.0 to 32.0 kg/m2, inclusive * must have normal renal function demonstrated by gfr, calculated by chronic kidney disease epidemiology collaboration formula * women must not be of childbearing potential (cannot become pregnant) exclusion criteria: * any significant acute or chronic medical illness * history of glucose-6-phosphodiesterase (g6pd) deficiency * personal or family history of cytochrome b5 reductase deficiency other protocol defined inclusion / exclusion criteria could apply
combined vitrectomy and femtosecond laser-assisted cataract surgery

Conditions: Macular Disease; Rhegmatogenous Retinal Detachment; Epiretinal Membrane; Cataract; Vitreous Hemorrhage; Vitreomacular Traction; Vitreous Cloudy

Summary: based on the progress of cataract surgery, intraocular lens development, vitreoretinal surgery and anesthesia technology in recent years, the purpose of this study is to develop a new type of more accurate and minimally invasive combined surgery for cataract and fundus diseases, and to evaluate the advantages and value of the surgery as well as related complications, so as to minimize the surgical trauma and obtain faster visual function recovery and better patient comfort. to provide new solutions for the growing demand of eye health care.

to evaluate the efficacy and complications of a new type of minimally invasive femtosecond laser assisted-cataract surgery (flacs) combined with pars plana vitrectomy (ppv) with two-step anesthesia in the treatment of various common fundus diseases such as rhegmatogenous retinal detachment (rrd), epiretinal membrane (erm), macular hole (mh), and vitreous opacity, complicated with cataract. it is mainly aimed at the following kinds of common fundus diseases with cataract performing ppv and cataract removal combined with monofocal or premium intraocular lens (iol) implantation： rrd complicated with cataract: flacs +ppv + iol+air; erm complicated with cataract: flacs +ppv+iol + epiretinal membrane peeling + ozurdex; mh complicated with cataract: flacs + ppv+ iol + internal limiting membrane peeling + air; vitreous opacity with cataract: flacs + ppv+ iol.

Eligibility criteria:
inclusion criteria: clinical diagnosis of following disease * rrd with cataract * erm with cataract * mh with cataract * vitreous opacity with cataract exclusion criteria: patients with history of following condition * intraocular surgery * ocular trauma * endophthalmitis * uveitis * glaucoma
atorvastatin/coenzymeq10 in congestive heart failure

Conditions: Congestive Heart Failure

Summary: the aim of this study is to compare the effect of addition of combination of atorvastatin/coenzymeq10 to standard congestive heart failure (chf) treatment versus addition of atorvastatin alone on chf outcomes.


Eligibility criteria:
inclusion criteria: * documented congestive hear failure * ejection fraction less than 40 percent * compensated heart failure without hospital admission during previous three months * no change in type and dose of medications in the last months * new york heart association function class 2 to 4 exclusion criteria: * acute coronary syndrome developing in the last month * active myocarditis * active pericarditis * uncontrolled hypertension * hepatic failure(child b,c) * pulmonary failure * renal failure * heart failure with killip classification 3 and 4

Keywords: coenzyme q10 atorvastatin clinical trial congestive heart failure
fesoterodine "add-on" male overactive bladder study

Conditions: Overactive Bladder Syndrome

Summary: to evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.


Eligibility criteria:
inclusion criteria: * men aged 40 years and above. * on a stable and well-tolerated dose of an alpha-blocker prescribed for luts for at least 6 weeks prior to screening (visit 1). * persistent symptoms of oab with urinary frequency \>=8 times/24 hours and micturition-related urgency episodes \>=3 episode/24 hours. exclusion criteria: * contraindication to fesoterodine (antimuscarinics). * previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline. * unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
a study of cm313 in subjects with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a multi-center, open-label, phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of cm313 in subjects with relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * subjects age ≥ 18 years. * subjects diagnosed with multiple myeloma. * subjects with measurable lesions. * women of childbearing potential with negative pregnancy testing. * subjects voluntarily signed the informed consent form and were able to comply with the provisions of this protocol. exclusion criteria: * previous treatment with any anti-cd38 therapy. * vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose. * positive for human immunodeficiency virus (hiv) antibodies. * syphilis antibody positive.
the effect of turkish music on pain and anxiety during childbirth

Conditions: Childbirth; Pain; Anxiety

Summary: nurses and midwives stand at the forefront during childbirth; their expertise in using natural pain relief techniques not only lessens the sensation of labor pain but also helps in calming the nerves of expectant mothers. these techniques are not only safe and easy to use but also kind on the pocket and devoid of any adverse effects. such methods can make childbirth experiences as positive and comfortable as possible. research has delved deeper into how music shaped by cultural tastes can significantly affect individuals, leading to a closer examination of how turkish tunes influence discomfort and nervousness during labor. the goal of this research was to explore how turkish melodies impact pain and anxiety feelings among women going through childbirth for the first time.


Eligibility criteria:
inclusion criteria: * primigravida women with term pregnancies (38-40 weeks) in the early active phase of labor * cervical dilatation between 4 and 6 cm exclusion criteria: * women who used narcotic analgesics or sedatives during labor * listened to music during childbirth * underwent induction * delivered via cesarean section

Keywords: nursing caries childbirth pain music anxiety
secondary access - femoral or radial in transcatheter aortic valve implantation?

Conditions: Valve Stenoses, Aortic

Summary: transcatheter aortic valve implantation (tavi) is a well known safe treatment for severe aortic stenosis. to perform tavi safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. while the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of tavi. the two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral tavi, to assess if radial access is superior to femoral access as a secondary access site.


Eligibility criteria:
inclusion criteria: * age \>18 years * undergoing transfemoral tavi with any commercially available transcatheter heart valve * suitable radial and secondary femoral access exclusion criteria: * primary arterial access via surgical cut-down * inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist * previously failed attempt to access bilateral radial arteries. * patient on hemodialysis

Keywords: tavi primary access secondary access
for patients with stones in gallbladder and bile duct stones at the same time, surgical removal of the gallbladder with the laparoscope is done in the same admission compared to its removal after 6 weeks following successful removel of the stones from the bile ducts by the side view endoscope

Conditions: Choledocholithiasis with Cholecystitis

Summary: the goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of cbd stones via ercp in comparison to late laparoscopic cholecystectomy 6 weeks after ercp. the main questions it aims to answer are: laparoscopic cholecystectomy * does index laparoscopic cholecystectomy associate with less recurrence of biliary complications? * is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ercp to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes. participants will: come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.

the study population of this randomized controlled trial study is those who underwent cbd stone clearance by ercp. the included fifty patients were stratified randomly into two groups: early and delayed. randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from cbd while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home. laparoscopic cholecystectomy was performed by the same surgical team for both groups.

Eligibility criteria:
inclusion criteria: * patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ercp exclusion criteria: patients with any of the following: * severe pancreatitis * suspicion of post-ercp bleeding or perforation, * associated malignancy * those in whom ercp failed to clear the cbd stones

Keywords: choledocholithiasis ercp early cholecystectomy
serum zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Conditions: Cystic Fibrosis

Summary: serum zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

serum zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis exclusion criteria: -
validity and reliability of the 12-item multiple sclerosis walking scale (12-ws) in subjects with spinal cord injury

Conditions: Spinal Cord Injuries; Gait Disorders, Neurologic

Summary: established gait assessments for subjects with spinal cord injury (sci) (6mwt, 10mwt, tug, scim iii and wisci ii) are widely used in the clinical and research setting. so far, no valid measurement exists that assesses the patients' perspective of walking ability in sci. as there is the 12-item multiple sclerosis walking scale (12-ws) to assess the patients' perspective on gait ability in patients with multiple sclerosis, it is hypothesized that the 12-ws would also be a valid instrument for subjects with incomplete sci. the main goal of this study is to collect data from clinical gait assessments in subjects with spinal lesions and to demonstrate that the 12-ws is a valid and reliable patient-reported outcome measurement for individuals with incomplete spinal cord injury.


Eligibility criteria:
inclusion criteria: * age 18-80 years * diagnosis of chronic spinal cord injury (\>6 months; cervical or thoracic motor incomplete traumatic or non-traumatic (ais c, d) above t12 * must have impaired walking function as demonstrated by neurological examination. exclusion criteria: * women who are pregnant or breast feeding * current orthopaedic problems of lower limbs * history of major cardiac condition (e.g., infarction, insufficiency (nyha ii-iv)) * history of major pulmonary condition (e.g., chronic obstructive pulmonary disease gold ii-iv * current major depression or psychosis * participation in another interventional study (except spectra-study) that may have an impact on walking function.
combined role of position emission tomography (pet) and magnetoencephalography (meg) in nonlesional epilepsy

Conditions: Epilepsy

Summary: the first aim of this study are to evaluate the lobar concordance of fdg-pet and meg with intracranial electrographic study in children with intractable partial epilepsy. the second aim is to determine if the combined role of fdg-pet and meg improve detection of epileptogenic zone as defined by invasive intracranial recordings.

children with poorly controlled epilepsy are extensively investigated with various tools including mr brain, electroencephalography (eeg), magnetoencephalography (meg) or position emission tomography (pet) scans. when mr brain does not show an abnormality, the patient is said to have nonlesional epilepsy. in these cases, it is even more crucial to be able to identify the epileptogenic zone, depending on availability of investigative tool. recognizing that individual modalities have limitations, the aim of this study is to determine if combining non-invasive investigations with meg and pet, which respectively evaluate the electrical and metabolic activity of the brain, could improve the children with intractable nonlesional epilepsy with meg and pet and compared this with invasive intracranial monitoring. the endpoint of the study being agreement on localizations of epileptogenic zone using pet and meg individually and in combination and comparing this with invasive intracranial monitoring.

Eligibility criteria:
inclusion criteria: * children between the ages 0-18 years with (1) nonlesional intractable focal epilepsy and (2) those with discordant clinical and eeg findings, who are potential surgical candidates exclusion criteria: * patients who are pregnant

Keywords: epilepsy pediatrics magnetoencephalography electroencephalography positron emission tomography
safety/tolerability study with azd1236 in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary aim of this study is to investigate the tolerability and safety of azd 1236 compared with placebo ("inactive substance") in copd patients by assessment of adverse events, vital signs and laboratory safety assessments.


Eligibility criteria:
inclusion criteria: * diagnosis of copd for 1 month * men or postmenopausal women * spirometry values indicating reduced lung function * smoking history equivalent to using 20 cigarettes a day for 10 years exclusion criteria: * any current respiratory tract disorders other than copd * requirement for regular oxygen therapy * use of oral or parenteral glucocorticosteroids within 30 days prior to the study

Keywords: copd
intrathecal non-preservative-free morphine with bupivacaine versus intrathecal bupivacaine alone for analgesia in unilateral inguinal hernia repair surgeries

Conditions: Pain, Postoperative

Summary: this study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.


Eligibility criteria:
inclusion criteria: * patients aged 18-65 years old. * both genders. * asa i and ii class. exclusion criteria: * patient refusal. * known local anesthetic (la) allergy. * skin lesions or infections at the site of needle insertion. * contraindications to spinal anesthesia. * failure of spinal anesthesia. * asa iii and vi class. * central or peripheral neuropathies. * severe respiratory or cardiac diseases.
a phase ⅱ study of an all-oral combination of low-dose etoposide/capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and/or taxanes

Conditions: Metastatic Breast Cancer

Summary: this is a single-center, open-lable, non-comparative, prospective, phase ⅱ efficacy and safety study. eligible patients are enrolled in a single group. the investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with etoposide/capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and/or taxanes.


Eligibility criteria:
inclusion criteria: * female patients between 18 and 65 years old * patients with metastatic breast cancer previousely treated with a/t * able and willing to give consent to participate in the study exclusion criteria: * pregnant or lactating females * other tumor history * instable complication (e.g., myocardial infarction within 6 months,arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection * concurrent disease or condition that would make the patient inappropriate for study participation * resist to participate in the study